Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

Venous Malformation Clinical Trial

Official title:

Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930952
• Other study ID #: 157-2018
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: June 2021
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Description:

Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent. The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 3, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: N/A to 12 Years

Eligibility

Inclusion Criteria: maxillofacial venous malformation -

Exclusion Criteria:

1. Patients with lung, liver, or kidney diseases

2. Patients with Klippel-Trenaunay syndrome

3. Patients mental or physical disabilities

Related Conditions & MeSH terms

• Congenital Abnormalities
• Venous Malformation

Intervention

Drug:
• Ethanol-amine Oleate Sclerotherapy Injection
Intralesional Sclerotherapy Injection

Locations

Country	Name	City	State
Egypt	Suez Canal University	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response	Complete Response - Marked Improvement - Moderate Improvement - No Response	12 months